The FDA has awarded U.S. orphan drug designation to Eydisbio Inc.’s EYD-001 (formerly HS-276), a highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis. Eydisbio plans to initiate clinical trials in the near future.
As Eli Lilly and Co. launches its recently approved Ebglyss (lebrikizumab) in an atopic dermatitis market already dominated by established biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), investors tuned into an Amgen Inc. investor call disclosing positive top-line phase III results for rocatinlimab, a monoclonal antibody that could potentially offer patients a new mechanism of action. While data from the Rocket Horizon study showed rocatinlimab hit all co-primary and secondary endpoints, the early findings fell below expectations in a highly competitive market.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the NIH has awarded Resvita Bio a $2.03 million phase II Small Business Innovation Research (SBIR) grant to advance RVB-003, a novel treatment for Netherton syndrome.
Roivant Sciences Ltd. has sold another company, this time offering up Dermavant Sciences Ltd. to Organon & Co. for $1.2 billion. The deal brings Organon into a crowded market for plaque psoriasis treatments. The massive amount comprises an up-front $175 million payment, along with a potential $75 million regulatory milestone and up to $950 million in commercial milestones. In the deal, Organon brings in Vtama (tapinarof) cream, a topical, aryl hydrocarbon receptor agonist for mild, moderate and severe plaque psoriasis in adults.
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
Phagocytosis – eliminating millions of dead cells every day – requires specialized cells such as macrophages, the true professionals, which migrate to engulf waste and dying cells.
Phagocytosis – eliminating millions of dead cells every day – requires specialized cells such as macrophages, the true professionals, which migrate to engulf waste and dying cells. But they are not the only ones that can perform this task, as scientists at Howard Hughes Medical Institute (HHMI) discovered when they investigated hair follicle stem cells (HFSCs), a tissue in constant regeneration, to clarify how dying cells are detected and cleared in the epithelium and the mesenchyme.
Azitra Inc. has obtained IND clearance from the FDA for a first-in-human phase I/II study of ATR-04 for moderate to severe EGFR inhibitor-associated dermal toxicity. The study is expected to begin by year-end.
RSS
